FDA.reportPublic FDA data

NATCH S-F11C System

Primary DI
06955792714694
Brand
NATCH S-F11C System
Company
Sansure Biotech Inc.
Model
S-F11C (US)
Device description
The NATCH S-F11C System is intended for extracting and purifying nucleic acids from human samples. Instrument should be used by trained operators in clinical laboratories processing samples for molecular testing
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06955792714694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955792714694069557927146946955792714694

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
400-871-6677xx@xx.xx

Regulatory Flags#

DUNS number
421167832
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Xvance 48C2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Xvance 96A2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Xvance 482026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Xvance 962026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Xvance 48A2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Xvance 48B2026-03-25
06955792701717Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block (Model: Q-Vera Prima 96 TAMR2025-11-19
06955792701670Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block (Model: Q-Vera Prima 96 AF402025-10-16
06955792700857Q-Vera Pico 6X qPCR Instrument48-well (8 wells x 6), 0.2 mL blocks2025-09-18
06955792701557Sample Storage ReagentLU-X1002E-48-62025-09-18
06955792701564Sample Storage ReagentLU-X1002E-48-32025-09-18
06955792701571Sample Storage ReagentLU-X1002E-48-12025-09-18
06955792701649Sample Storage ReagentLU-X1002E-48-3b2025-09-18
06955792701656Sample Storage ReagentLU-X1002E-48-6b2025-09-18
06955792700864Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block2024-10-29
06955792714977Nucleic Acid Extraction-Purification Kit 4.0S50016E-48B2023-09-18
06955792714960Nucleic Acid Extraction-Purification Kit 4.0S50016E-48A2023-09-15
06955792713666Nucleic Acid Extraction-Purification Kit 3.0S50016E-482023-07-28
06955792713673Nucleic Acid Extraction-Purification Kit 3.0S50016E-962023-07-28
06955792714366Nucleic Acid Extraction-Purification Kit 2.0S50016E-48C2023-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B708ABFVR020XCELLAPEX BIOLOGIX , LLCJJH2026-03-26
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitPROMEGA CORPORATIONJJH2026-02-16
04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810268IntelliPrep FFPE DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121403TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121441TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121458TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122097TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122103TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122158TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122165TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122370TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122387TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122431TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122660TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122707TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122882TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122899TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07